Evidence map›Paper›PMID 33216434›Full record

ArticlePharmacoepidemiology and drug safety2021

Effectiveness of risk minimisation measures for valproate: A cross-sectional survey among physicians in Europe.

Massoud Toussi, Bardoulat Isabelle, Stephanie Tcherny-Lessenot, Hanka de Voogd, Vasilis Dimos, Sigal Kaplan

Open access · hybridAbstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 5 countries.

Massoud ToussiReal World Evidence Solutions, IQVIA, La Défense Cedex, France.ORCID 0000-0001-6780-0676
Bardoulat IsabelleReal World Evidence Solutions, IQVIA, La Défense Cedex, France.
Stephanie Tcherny-LessenotEpidemiology and Benefit-Risk, Sanofi Aventis R&D, Chilly-Mazarin, France.
Hanka de VoogdGlobal Clinical Research, Mylan, Amstelveen, The Netherlands.
Vasilis DimosDepartment of Pharmacovigilance (medical section), Demo S.A., Athens, Greece.
Sigal KaplanGlobal Patient Safety & Pharmacovigilance, Teva Pharmaceutical Industries Ltd, Netanya, Israel.ORCID 0000-0002-3352-8480
IQVIA (France) · FRAthens Medical Center · GRHewlett-Packard (Netherlands) · NLSanofi (France) · FRTeva Pharmaceuticals (Israel) · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study evaluated the effectiveness of risk minimisation measures (RMMs) implemented following the 2014 referral for valproate in Europe.

methodsCross-sectional survey was conducted over 2-month period in 2016 among physicians who prescribed valproate in France, Germany, the United Kingdom, Spain and Sweden. The web-based questionnaire included five endpoints to evaluate physicians' knowledge on (a) prescribing valproate only for epilepsy and bipolar disorder in women if other treatments were ineffective or not tolerated; (b) ensuring supervision by experienced physicians while treating these conditions; (c) considering alternative treatments for women planning pregnancy, regular review of treatment needs and re-assessing the benefit-risk balance in women and girls reaching puberty; (d) informing patients about the risks of taking valproate during pregnancy and (e) advising women on effective contraception during their treatment.

resultsAmong 1153 physicians, 95.5% responded prescribing valproate for epilepsy and bipolar disorder in women only if other treatments are ineffective/not tolerated; 66.5% supervised while treatment; 76.6% considered alternative treatments for women planning pregnancy; 92.1% informed patients about the risks of taking valproate during pregnancy and 94.4% advised patients on the use of effective contraception during its treatment. Overall, 25.8% physicians recalled receiving both educational material (EM) and Dear Healthcare Professional Communication (DHPC). All endpoint rates were higher for physicians who acknowledged receipt of both DHPC and EM compared to physicians who did not receive them.

conclusionsAlthough results varied across geography and physician speciality, majority of physicians had good knowledge about the indication and safety aspects of prescribing and using valproate.

Indexed as

PhysiciansValproic AcidAnticonvulsantsCross-Sectional StudiesEuropeFemaleHumansPregnancyAnticonvulsantsValproic AcidDirect Healthcare Professional Communicationpharmacoepidemiologyprescribing behaviourrisk minimisation measuresvalproate

Identifiers

PMID33216434
PMCPMC7894483
OpenAlexW3098702548

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.